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临床试验/NCT07453407
NCT07453407招募中不适用

J-VALVE Transcatheter Aortic Valve Replacement Versus Surgical Aortic Valve Replacement for Patients With Aortic Regurgitation Therapy

Second Affiliated Hospital, Zhejiang University, School of Medicine28 个研究点 分布在 1 个国家目标入组 1,250 人开始时间: 2026年3月5日最近更新:
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适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,250
试验地点
28
主要终点
All stroke
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The overall purpose of ART trial is to establish the Safety and Efficacy of the J-VALVE Transcatheter Aortic Valve Replacement Versus Surgical Aortic Valve Replacement in Patients with Grade≥3+ Native Aortic Regurgitation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —（Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •1) Age ≥65 years；
  • •2) a. Symptomatic patients with severe AR b. Asymptomatic patients with severe AR and evidence of LV function impairment (per current ESC / ACC guidelines) Any of the following perimeters
  • •LVESD >50 mm
  • •LVESDi >22 mm/m2
  • •LVESVi >45 mL/m2
  • •normal LV systolic function at rest (LVEF >55%), and a progressive decline in LVEF on at least 3 serial studies to the low-normal range (LVEF 55% to 60%) or a progressive increase in LV dilation into the severe range (LV end-diastolic dimension [LVEDD] >65 mm),
  • •3) Evaluated by a multi-disciplinary heart team to be suitable for both surgery and transcatheter valve replacement
  • •4) Informed of the nature of the study, agrees to its provisions, has provided written informed consent, and agrees to comply with all required post-procedure follow-up visits

排除标准

  • •1. Confirmed moderate or less AR severity (Grade≤2+) by core laboratory evaluation
  • •2. Moderate or severe aortic valve stenosis
  • •3. Mixed with clinical relevant severe mitral or tricuspid disease that require valve intervention
  • •4. Pre-existing mechanical or bioprosthetic valve in any position. (of note, mitral ring is not an exclusion)
  • •5. Subject is high-risk for SAVR as determined by the local heart team
  • •6. Subject refuses SAVR as a treatment option
  • •7. Subject is selected for aortic valve repair or aortic surgery
  • •8. Need for emergency surgery or TAVR for any reason
  • •9. Anatomical exclusion criteria (ANY of the following):
  • •Aortic Annulus Perimeter <53 mm or >94 mm measured by CT
  • •Maximal ascending aortic diameter ≥50 mm
  • •Congenital aortic valve disease including unicuspid, bicuspid, or quadricuspid aortic valve anatomy
  • •Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (e.g., calcification, tortuosity).
  • •Significant abdominal or thoracic aortic disease (such as porcelain aorta, severe calcification, aortic coarctation, etc.) that preclude safe passage of the delivery system or cannulation and aortotomy for surgical AVR.
  • •10. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the screening visit
  • •11. Cardiac resynchronization therapy (CRT) device implantation within 30 days of the screening visit
  • •12. Any condition considered a contraindication to mechanical circulatory support
  • •13. Hostile chest or conditions or complications from prior surgery that preclude safe reoperation (e.g., mediastinitis, radiation damage, abnormal chest wall, adhesion of aorta or IMA to sternum, etc.)
  • •14. Subject refuses blood transfusion
  • •15. Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement/intervention
  • •16. Evidence of acute myocardial infarction within 30 days of the screening visit
  • •17. Any percutaneous coronary or peripheral interventional procedure performed within 30 days of the screening visit (Subjects with placement of coronary or peripheral stent(s) should be assessed for the ability to safely proceed with SAVR within the protocol timeframe)
  • •18. Complex coronary artery disease (one of the following):
  • •Unprotected left main coronary artery disease ≥50%
  • •True bifurcation lesion (Medina: 1.1.1) and the diameter of the branch vessels is >2.5 mm
  • •Chronic total occlusion (CTO)
  • •Long lesion, expected stent length >38 mm
  • •Multivessel lesion (at least 2 coronary arteries require interventional treatment)
  • •Need to use multiple stents (planned > 3 stents)
  • •Lesion with in-stent restenosis
  • •Severe calcification lesion
  • •Coronary ostial lesion
  • •Heart Team assessment that optimal revascularization cannot be performed with either CABG at the time of SAVR or PCI at the time of TAVR.
  • •19. Symptomatic carotid or vertebral artery disease or carotid intervention within 30 days of the screening visit
  • •20. Stroke or transient ischemic attack (TIA) within 90 days of the screening visit
  • •21. Severe left ventricular dysfunction, defined as a resting left ventricular ejection fraction <25%; or left ventricular end-systolic diameter (LVESD) >70 mm; or the presence of an artificial heart or left ventricular assist device; or being listed for heart transplantation or status post heart transplantation.
  • •22. Moderate to severe or worse right ventricular dysfunction on resting echocardiogram according to core laboratory
  • •23. Cardiac imaging (echocardiography, CT, and/or MRI) evidence of intracardiac mass, thrombus or vegetation
  • •24. Left atrial thrombus without continuous appropriate anticoagulation within 90 days of the study procedure
  • •25. Uncontrolled atrial fibrillation (i.e., resting heart rate >120 bpm)
  • •26. Hemodynamically significant hypertrophic Obstructive cardiomyopathy (HOCM), Peak LVOT gradient ≥50mmHg (resting or provoked) ESC 2022/ ACC 2020
  • •27. Untread Leukopenia (WBC<3.0*109/L), Untread Thrombocytopenia (Platelet count <50*109), history of bleeding diathesis or coagulopathy, or hypercoagulable states, Acute posthemorrhagic anemia (hemoglobin <9.0 g/dL)
  • •28. Severe chronic obstructive pulmonary disease (COPD) (FEV1 <50% predicted) or currently on home oxygen
  • •29. Severe pulmonary hypertension (e.g., PA systolic pressure ≥2/3 systemic pressure)
  • •30. Severe chronic liver disease (Child-Pugh C) or any active liver disease
  • •31. Renal insufficiency (eGFR<30mL/min/1.73m²) and/or requiring chronic peritoneal dialysis at the time of screening and/or requiring chronic hemodialysis at the time of screening
  • •32. Ongoing sepsis or active infective endocarditis with ongoing antibiotic (including suppressive) therapy or positive blood cultures within 6 weeks
  • •33. Subject has a known hypersensitivity or contraindication to all anticoagulation/antiplatelet medications (or inability to be anticoagulated for the index procedure), implant-related materials, or sensitivity to contrast media which cannot be adequately pre-medicated
  • •34. Inability to tolerate anti-thrombotic/anticoagulation therapy during or after the valve implant procedure
  • •35. Active gastrointestinal bleeding precluding anticoagulation or antiplatelet therapy
  • 另有 7 项未显示

研究组 & 干预措施

Surgical aortic valve replacement（SAVR）

Other

Surgical aortic valve replacement（SAVR）using commercially available surgical biological aortic valve replacement device

干预措施: Commercially available surgical biological aortic valve replacement device (Device)

Transcatheter aortic valve replacement (TAVR)

Experimental

Transcatheter aortic valve replacement (TAVR) using J-VALVE Transfemoral Aortic Valve system

干预措施: J-VALVE Transfemoral Aortic Valve system (Device)

结局指标

主要结局

All stroke

时间窗: 12 months

Number of patients with stroke

All-cause mortality

时间窗: 12 months

All-cause mortality at 12 months

Unplanned cardiac rehospitalization

时间窗: 12 months

Number of patients who had unplanned cardiac rehospitalization

次要结局

  • Health-related quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ-23)(30 days)
  • Composite primary endpoints(30 days)
  • Echocardiographic effective orifice area(30 days)
  • Moderate or greater patient prosthesis mismatch as measured by echocardiography(30 days)
  • Cardiovascular rehospitalization(30 days)
  • New-onset atrial fibrillation(30 days)
  • Length of index hospitalization(Pre-intervention/procedure surgery)

研究者

发起方
Second Affiliated Hospital, Zhejiang University, School of Medicine
申办方类型
Other
责任方
Sponsor

研究点 (28)

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